Diferencia mínima clínica importante en calidad de vida relacionada con la salud
e202106074
Palabras clave:
Diferencia mínima clínica importante, Diferencia mínima importante, Significación clínica, Cambio relevante, Resultados reportados por pacientes, Calidad de vida relacionada con la saludResumen
Una de las limitaciones para el uso de los Cuestionarios de Calidad de Vida Relacionada con la Salud y de los resultados reportados por pacientes es la dificultad de interpretar los valores obtenidos. La diferencia mínima clínica importante es una medida que ayuda a comprender los resultados de estos cuestionarios y valorar la relevancia clínica del efecto conseguido por la intervención realizada.
En este trabajo revisamos el concepto de diferencia mínima clínica importante, describimos los métodos utilizados para su obtención y exponemos sus dificultades, limitaciones y aplicabilidad.
Dentro de los resultados reportados por pacientes y, particularmente, en los de calidad de vida, la diferencia mínima clínica importante es una herramienta que ayuda a los clínicos a utilizar correctamente las escalas de medida e interpretar el efecto de las intervenciones. Con este artículo esperamos facilitar la implantación y uso de la diferencia mínima clínica importante y los Cuestionarios de Calidad de Vida Relacionada con la Salud en la práctica habitual con nuestros pacientes.
Descargas
Citas
Ojo B, Genden EM, Teng MS, Milbury K, Misiukiewicz KJ, Badr H. A systematic review of head and neck cancer quality of life assessment instruments. Oral Oncol. 2012;48(10):923-937.
Johnston BC, Ebrahim S, Carrasco-Labra A, Furukawa TA, Patrick DL, Crawford MW et al. Minimally important difference estimates and methods: a protocol. BMJ Open. 2015;5(10):e007953.
Guyatt GH, Osoba D, Wu AW, Wyrwich KW, Norman GR. Methods to explain the clinical significance of health status measures. Mayo Clin Proc. 2002;77(4):371-383.
Jayadevappa R, Cook R, Chhatre S. Minimal important difference to infer changes in health-related quality of life-a systematic review. J Clin Epidemiol. 2017;89:188-198.
Wilson MK, Karakasis K, Oza AM. Outcomes and endpoints in trials of cancer treatment: The past, present, and future. Lancet Oncol. 2015;16(1):e32-e42.
Tsakos G, Allen PF, Steele JG, Locker D. Interpreting oral health-related quality of life data. Community Dent Oral Epidemiol. 2012;40(3):193-200.
Norman GR, Sloan JA, Wyrwich KW. Interpretation of changes in health-related quality of life the remarkable universality of half a standard deviation. Med Care. 2003;41(5):582-592.
Cocks K, King MT, Velikova G, Fayers PM, Brown JM. Quality, interpretation and presentation of European Organisation for Research and Treatment of Cancer quality of life questionnaire core 30 data in randomised controlled trials. Eur J Cancer. 2008;44(13):1793-1798.
Slade GD, Nuttall N, Sanders AE, Steele JG, Allen PF, Lahti S. Impacts of oral disorders in the United Kingdom and Australia. Br Dent J. 2005;198(8):489-493.
Jaeschke R, Singer J, Guyatt GH. Measurement of health status. Ascertaining the minimal clinically important difference. Control Clin Trials. 1989;10(4):407-415.
Copay AG, Subach BR, Glassman SD, Polly DW, Schuler TC. Understanding the minimum clinically important difference: a review of concepts and methods. Spine J. 2007;7(5):541-546.
Schünemann HJ, Guyatt GH. Commentary-goodbye M(C)ID! Hello MID, where do you come from? Health Serv Res. 2005;40(2):593-597.
McGlothlin AE, Lewis RJ. Minimal clinically important difference: defining what really matters to patients. JAMA. 2014;312(13):1342-1343.
King MT. A point of minimal important difference (MID): a critique of terminology and methods. Expert Rev Pharmacoeconomics Outcomes Res. 2011;22(2):171-184.
Ousmen A, Touraine C, Deliu N, Cottone F, Bonnetain F, Efficace F et al. Distribution- and anchor-based methods to determine the minimally important difference on patient-reported outcome questionnaires in oncology: A structured review. Health Qual Life Outcomes. 2018;16(1):1-12.
U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research, U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance. Health Qual Life Outcomes. 2006;4:79.
Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL. Defining the clinically important difference in pain outcome measures. Pain. 2000;88(3):287-294.
Lydick E, Epstein RS. Interpretation of quality of life changes. Qual life Res. 1993;2(3):221-226.
Maringwa J, Quinten C, King M, Ringash J, Osoba D, Coens C et al. Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients. Ann Oncol. 2011;22(9):2107-2112.
Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J. 2002;19(3):398-404.
Revicki D, Hays RD, Cella D, Sloan J. Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. J Clin Epidemiol. 2008;61(2):102-109.
Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care. 1989;27(3 Suppl):S178-89.
Cohen J. Statistical Power Analysis for the Behavioural Sciences. Acad Press. 1989:37-42.
Feinstein AR. Indexes of contrast and quantitative significance for comparisons of two groups. Stat Med. 1999;18(19):2557-2581.
Miller GA. The magical number seven, plus or minus two: some limits on our capacity for processing information. 1956. Psychol Rev. 1994;101(2):343-352.
Ringash J, O’Sullivan B, Bezjak A, Redelmeier DA. Interpreting clinically significant changes in patient-reported outcomes. Cancer. 2007;110(1):196-202.
Høxbroe Michaelsen S, Grønhøj C, Høxbroe Michaelsen J, Friborg J, von Buchwald C. Quality of life in survivors of oropharyngeal cancer: A systematic review and meta-analysis of 1366 patients. Eur J Cancer. 2017;78:91-102.
Barrett B, Brown D, Mundt M, Brown R. Sufficiently important difference: Expanding the framework of clinical significance. Med Decis Mak. 2005;25(3):250-261.
Hutcheson KA, Barrow MP, Lisec A, Barringer DA, Gries K, Lewin JS. What is a clinically relevant difference in MDADI scores between groups of head and neck cancer patients? Laryngoscope. 2016;126(5):1108-1113.
Johnston BC, Thorlund K, Da Costa BR, Furukawa TA, Guyatt GH. New methods can extend the use of minimal important difference units in meta-analyses of continuous outcome measures. J Clin Epidemiol. 2012;65(8):817-826.
Angst F, Verra ML, Lehmann S, Aeschlimann A. Responsiveness of five condition-specific and generic outcome assessment instruments for chronic pain. BMC Med Res Methodol. 2008;8:26.
Wyrwich KW, Tierney WM, Wolinsky FD. Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol. 1999;52(9):861-873.
Wyrwich KW, Tierney WM, Wolinsky FD. Using the standard error of measurement to identify important changes on the Asthma Quality of Life Questionnaire. Qual Life Res. 2002;11(1):1-7.
Wyrwich KW, Nienaber NA, Tierney WM, Wolinsky FD. Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care. 1999;37(5):469-478.
Cella D, Eton DT, Lai J-S, Peterman AH, Merkel DE. Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy (FACT) anemia and fatigue scales. J Pain Symptom Manage. 2002;24(6):547-561.
Eton DT, Cella D, Yost KJ, Yount SE, Peterman AH, Neuberg DS et al. A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. J Clin Epidemiol. 2004;57(9):898-910.
Shikiar R, Harding G, Leahy M, Lennox RD. Minimal important difference (MID) of the Dermatology Life Quality Index (DLQI): results from patients with chronic idiopathic urticaria. Health Qual Life Outcomes. 2005;3:36.
García Seara J, Gude F, Cabanas P, Martínez Sande JL, Fernández López X, Elices J et al. Quality of life differences in patients with typical atrial flutter following cavotricuspid isthmus ablation. Rev Esp Cardiol. 2011;64(5):401-408.
Aaronson N, Alonso J, Burnam A, Lohr KN, Patrick DL, Perrin E et al. Assessing health status and quality-of-life instruments: attributes and review criteria. Qual Life Res. 2002;11(3):193-205.
Rejas J, Ruiz M, Pardo A. El error estándar de medida: ¿una alternativa a la diferencia mínimamente importante para evaluar cambios en las medidas de salud autopercibida? An Med Interna. 2007;24:415-420.
Bauer S, Lambert MJ, Nielsen SL. Clinical significance methods: a comparison of statistical techniques. J Pers Assess. 2004;82(1):60-70.
Hays RD, Brodsky M, Johnston MF, Spritzer KL, Hui K-K. Evaluating the statistical significance of health-related quality-of-life change in individual patients. Eval Health Prof. 2005;28(2):160-171.
Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59(1):12-19.
Wyrwich KW, Bullinger M, Aaronson N, Hays RD, Patrick DL, Symonds T et al. Estimating clinically significant differences in quality of life outcomes. Qual Life Res. 2005;14(2):285-295.
Hamidou Z, Dabakuyo TS, Bonnetain F. Impact of response shift on longitudinal quality-of-life assessment in cancer clinical trials. Expert Rev Pharmacoecon Outcomes Res. 2011;11(5):549-559.
Kvam AK, Wisloff F, Fayers PM. Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma. Health Qual Life Outcomes. 2010;8:79.
Yost KJ, Cella D, Chawla A, Holmgren E, Eton DT, Ayanian JZ et al. Minimally important differences were estimated for the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) instrument using a combination of distribution- and anchor-based approaches. J Clin Epidemiol. 2005;58(12):1241-1251.
Wright A, Hannon J, Hegedus EJ, Kavchak AE. Clinimetrics corner: A closer look at the minimal clinically important difference (MCID). J Man Manip Ther. 2012;20(3):160-166.
Rollon-Ugalde V, Coello-Suanzes JA, Lopez-Jimenez AM, Herce-Lopez J, Toledano-Valero P, Montero-Martin J et al. Oral health-related quality of life after dental treatment in patients with intellectual disability. Med Oral Patol Oral Cir Bucal. 2020;25(5):e576-e583.
Revicki DA, Cella D, Hays RD, Sloan JA, Lenderking WR, Aaronson NK. Responsiveness and minimal important differences for patient reported outcomes. Health Qual Life Outcomes. 2006;4:1-5.
Descargas
Publicado
Cómo citar
Licencia
Derechos de autor 2021 Ángel Rollón-Mayordomo, Virginia Rollón-Ugalde, Ana M. López-Jiménez, Pedro Infante-Cossio
Esta obra está bajo una licencia internacional Creative Commons Atribución-NoComercial-SinDerivadas 4.0.
Usted es libre de:
Compartir — copiar y redistribuir el material en cualquier medio o formato.
La licenciante no puede revocar estas libertades en tanto usted siga los términos de la licencia.
Bajo los siguientes términos:
Atribución — Usted debe dar crédito de manera adecuada , brindar un enlace a la licencia, e indicar si se han realizado cambios. Puede hacerlo en cualquier forma razonable, pero no de forma tal que sugiera que usted o su uso tienen el apoyo de la licenciante.
NoComercial — Usted no puede hacer uso del material con propósitos comerciales.
SinDerivadas — Si remezcla, transforma o crea a partir del material, no podrá distribuir el material modificado.
No hay restricciones adicionales — No puede aplicar términos legales ni medidas tecnológicas que restrinjan legalmente a otras a hacer cualquier uso permitido por la licencia.
Avisos:
No tiene que cumplir con la licencia para elementos del material en el dominio público o cuando su uso esté permitido por una excepción o limitación aplicable.
No se dan garantías. La licencia podría no darle todos los permisos que necesita para el uso que tenga previsto. Por ejemplo, otros derechos como publicidad, privacidad, o derechos morales pueden limitar la forma en que utilice el material.
